Solid Dispersion Controlled Release: Effect of Particle Size, Compression Force and Temperature

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Abstract
Solid dispersions are dynamic systems, a careful control of processing variables is required to produce desired physicochemical properties of these systems. The influence of drug particle size, dispersion temperature and compression force on the release rate of theophylline from solid dispersed system tablets was studied. Theophylline base (micronized and granulate) were embedded into a polymeric mixture of PEG and acrylic/methacrylic esters at controlled temperature and shock cooled. Tablets were made at two compressional forces and drug release was measured spectrophotometrically over a period of fifteen hours. The release rate of drug dispersed in these insoluble matrices was independent of particle size but not of hardness. However, variations in ratios of polymeric mixture and dispersion temperature controls the drug release rate from inert matrix more effectively than such factors as drug particle size and lower range of tablet hardness. The fast cooling produced excellent reproducibility of drug content throughout the entire entrapment product. X-ray diffraction study demonstrated no changes in crystalline form of theophylline.